EP2467190B1 - Polarisationsvorrichtung und implantationssystem - Google Patents

Polarisationsvorrichtung und implantationssystem Download PDF

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Publication number
EP2467190B1
EP2467190B1 EP10732290.1A EP10732290A EP2467190B1 EP 2467190 B1 EP2467190 B1 EP 2467190B1 EP 10732290 A EP10732290 A EP 10732290A EP 2467190 B1 EP2467190 B1 EP 2467190B1
Authority
EP
European Patent Office
Prior art keywords
implant
coil
contact
electrically
effective component
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP10732290.1A
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German (de)
English (en)
French (fr)
Other versions
EP2467190A2 (de
Inventor
Werner Kraus
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Geiges Bjarne
Original Assignee
Geiges Bjarne
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Publication date
Application filed by Geiges Bjarne filed Critical Geiges Bjarne
Publication of EP2467190A2 publication Critical patent/EP2467190A2/de
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Publication of EP2467190B1 publication Critical patent/EP2467190B1/de
Not-in-force legal-status Critical Current
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/326Applying electric currents by contact electrodes alternating or intermittent currents for promoting growth of cells, e.g. bone cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode

Definitions

  • the invention relates to a device for polarizing implants and an implantation system with such a device.
  • the osteosynthesis serves to load-stable fixation of the fragments of a broken or diseased bone in its uninjured, natural shape by implanted screws, support plates, wires, bone marrow nails and the like, which are generally made of stainless steel or titanium alloys. These osteosynthetic agents allow for rapid mobilization of the patient while immobilizing the damaged bone, which is an essential prerequisite for its healing.
  • MRSA multi-resistant Staphylococcus aureus
  • the technique of transmission works according to the transformer principle:
  • the injured or diseased body region is characterized by an extremely low frequency sinusoidal magnetic field having a frequency of about 1 to 100 Hz - preferably from 4 to 20 Hz - and a magnetic flux density of 0.5 to 5 Flooded mT (5 to 50 Gauss), which is generated by a functional current generator in one or more - primary outer current coils, in which the provided with the osteosynthetic body part is introduced.
  • These extremely low frequency electromagnetic fields penetrate the tissue largely lossless, including any clothing and a plaster cast, as well as the non-magnetic (austenitic) support metals of osteosynthesis.
  • the so-called transformer implanted.
  • the induced in the transmitter electro-potentials are thus brought into action in the area of the bone lesion and generally in the tissue adjacent to the osteosynthetic agents.
  • FIG. 1 Another example of an implant that can be used in the context of electro-osteotherapy is in the DE 23 11 817 C1 and the US 3,918,440 specified.
  • the push-button screw described here is contacted via a push-button with a transformer coil arranged outside of the screw and thus becomes part of electro-osteotherapy.
  • the invention has for its object to provide a way to variant-rich integration of implants in electro-osteotherapy, in particular, a compact arrangement is sought, which is easily preserved over the desired implantation duration.
  • the invention consists in a device for polarizing at least two spatially separated, electrically at least partially conductive implants according to claim 1.
  • the implants so not only for fixation purposes and as an electrode, but the first implant also serves as a carrier of the transmitter coil.
  • the counterelectrode is formed by another structurally identical or completely different type of implant in that a line connection is made from the coil carried by the first implant to the other implant, whereby a plurality of implants are readily connected by such line connections can be contacted, so that each of these implants forms a counter electrode to the implant carrying the coil. All involved implants can be constructed identical or different.
  • the coil is arranged in a cavity of the first implant.
  • the first contact device electrically contacts the first implant within the cavity.
  • the coil is safely housed in the human body.
  • the connection between the coil and the first implant is completely safe and immune to interference since this connection is in no way affected by any processes in the human body.
  • the coil is wound on a magnetically conductive core. In this way, the conversion of the energy applied by an external magnetic field into an electrical voltage becomes more efficient.
  • the invention develops its advantages particularly in connection with the fact that the at least one second implant is also a bone screw.
  • Bone screws can perform a variety of functions and are comparatively easy to implant in various positions of the body.
  • the present invention can be used particularly flexibly in connection with bone screws.
  • the invention is usefully further developed in that the at least one second contact device has a contact push button, via which a mechanical and electrical connection to the at least one second implant can be produced. Since there is a simple handling of the components to be implanted during the operation, the connection of the second contact device with the second implant via a contact push button is a particularly useful solution. A push button is able to simultaneously make a mechanical and an electrical connection.
  • At least one insulating sheath is provided, by which the contact push button of the at least one second contact device is electrically isolable from surrounding tissue. This avoids that bone growth takes place in the region of the contact push button, which is particularly with regard to could be a hindrance to the explantation of the implant or could require additional costly measures.
  • the coil is held by a coil carrier, via which a mechanical contact with the first implant can be produced.
  • At least one insulating sheath is provided by which a proximal region of the coil carrier can be electrically insulated from surrounding tissue.
  • the bobbin is particularly easy to handle, if it is provided that the mechanical contact comprises a latching connection.
  • the coil carrier receives a distributor, with which a plurality of second contact devices are connected.
  • the lines that lead to the various second contact devices are thus securely contacted within the bobbin.
  • the present invention can be developed such that the coil is part of an electrical circuit which has at least one further electrically active component in addition to the coil. As a result, additional functionalities can be provided.
  • an accumulator is provided which is connected in parallel to the coil. This makes it possible to maintain the electrical potentials of the implants even when no external magnetic field is present.
  • the accumulator is charged during the treatment with external magnetic field, for which purpose a rectification of the induced AC voltage is required. In the absence of the external magnetic field, the accumulator can then restore the stored energy by generating an electrical voltage and an associated current flow.
  • a function generator is provided as a further electrically active component.
  • the signal shaping for generating the electric fields in the region of the implants does not have to be carried out alone or at all by the external magnetic field. Rather, it is possible to provide a function generator that performs this task. This is particularly useful in the context of a likewise provided accumulator, which is charged by the coil in the presence of external magnetic field. The latter can then provide the voltage required for the operation of the function generator even in the absence of an external magnetic field.
  • a circuit which is suitable for modifying an AC voltage provided by the device so that the first implant has at least predominantly a first polarity, while the second implant is at least predominantly has a second polarity opposite to the first polarity.
  • osteogenesis depends on the polarity of the respective electrode. The cathode promotes osteogenesis, and the anode impedes this. Consequently, by appropriate rectification, the right action can be taken, depending on the situation.
  • the circuit may be implemented discretely or as an integrated circuit, preferably as an ASIC.
  • the further electrically active component can be arranged in the cavity of the first implant. All electrically active components are thus arranged in one place, so that one can be content to contact the second implants with an already described push button.
  • the further electrically active component can be arranged in a cavity of the second implant. This solution is preferable if there is not enough room in the first implant to accommodate all the components.
  • the invention furthermore relates to an implantation system having a device according to the invention and at least one second implant, which is at least partially conductive and to be implanted spatially separated from the first implant.
  • an electromagnetically inducible pickup coil is proposed over a magnetically conductive soft iron core, which is inserted into the lumen of a hollow screw anchored in the region of a bone defect.
  • the pickup coil is wrapped in an insulating layer of epoxy or silicone and is electrically connected at its lower end with a spiral or plate spring. With this she contacts the bone screw when inserted into the lumen of the screw.
  • the upper end of the coil core projects beyond the coil winding and is received by a sleeve made of stainless steel or titanium and mechanically held by gluing with this.
  • the sleeve has at its upper end the shape of a push button, which is pressed after insertion of the pickup coil in a seat in the head of the bone screw.
  • the upper coil end of the pickup coil leads within the sleeve, isolated from this, for electrical distribution to several, for example 1 to 3 or 4 cable connections, for example, 3 to 5 cm in length, by electrical pressure contacts in each case in the head of other bone screws, these against the Bolt bearing pickup coil polarized.
  • the system according to the invention can be mono- or unipolar Induction screws serve any hollow screws, as they are used for fixation and immobilization of bone fragments use.
  • the hollow screws are preferably made of titanium alloys, on the surface of which forms a poorly conductive oxide layer in the tissue. This can be prevented by coating with highly conductive titanium niobium oxinitride (Ti, Nb) ON.
  • Ti, Nb highly conductive titanium niobium oxinitride
  • Another feature offers the possibility of miniaturization of the pickup coil. By changing the steepness of the rising or falling at the same frequency edges of the sinusoidal oscillations of the inducing electromagnetic field, the induced voltage can be maintained at the same amplitude be increased and thus a loss resulting from the miniaturization of the pickup, can be compensated.
  • the monopolar induction screw system (MISS) according to the invention differs in particular by the spatial distribution of the stimulating electric field in the bone. While the course of the electric field in the bioplar induction screw reaches only the tissue layer directly adjacent to the surface of the screw, in the monopolar induction screw system according to the invention the induced electric field extends between them over the entire volume of, for example, an extensive fracture zone or a pathologically altered bone area, which must be filled up with natural and foreign bone or bone substitute material and biologically integrated. These requirements are ideally met by the monopolar induction screw system.
  • the device according to the invention is also the "push-button screw" after DE 23 11 817 C2 and US 3,918,440 clearly superior.
  • Materials for the insulating material in the coil holder are, for example, polyetheretherketone (PEEK) and polyvinylidene fluoride (PVDF). Both materials are biocompatible, autoclavable and gamma ray sterilizable.
  • PEEK polyetheretherketone
  • PVDF polyvinylidene fluoride
  • the cable connections are preferably made of quadruple coiled pacemaker wire MP35N with cobalt-based alloy.
  • the bone screws are preferably made of a titanium alloy with a conductive layer of titanium niobium oxynitride (Ti, Nb) ON.
  • the unwanted, possibly dangerous bone sheath around the contact area can be avoided by an insulating sheath around the push button, the length of which also envelops the head of the contacted bone screw down, in such a way that any direct electrical contact with the Bone is safely avoided.
  • the sheath may suitably be part of the insulation of the distributor in the head of the push-button contact made of PEEK or PVDF and close with its upper end, for example in the form of a mushroom cap containing the pickup coil and the cable distributor push-button insert.
  • Fig. 1 shows a schematic perspective view of an implantation system according to the invention with associated bone screws.
  • Fig. 2 shows a schematic perspective, partially sectioned view of a polarizing device according to the invention.
  • the polarization device 10 includes a coil 20 wound on a magnetically conductive core 32.
  • a first pole 22 of the coil 20 is connected to a contact device 26 in connection, which is designed as a contact spring.
  • a second pole 24 of the coil 20 leads to a distributor 42.
  • Three further contact devices 28 are connected to this distributor 42. These contact devices 28 comprise an electrical line 30 and contact pushbuttons 34 at the ends of the lines 30 facing away from the distributors 42 Fig.
  • the coil 20 is held by a bobbin 40, for example, indirectly, characterized in that the magnetically conductive core 32 on which the coil 20 is wound, in a recess 44 of the bobbin and non-positively fit.
  • the coil is surrounded by an insulating jacket 46 and so protected against it, in contrast to the connected via the first pool 22 contact device 26 with the bone screw in electrical contact.
  • the distributor 42 is embedded in an insulating compound 48, for example consisting of PEEK or PVDF.
  • the housing 50 which has the recess 44 for holding the coil 20 or the magnetically conductive core 22, has an at least partially circumferential groove 52.
  • the bone screw 12, which is to be contacted with the first contact device 26, has a corresponding complementary device, So that a stable locking connection between the housing 50 and the bone screw 12 can be provided.
  • Fig. 3 shows a schematic perspective view of an implantation system according to the invention with associated bone screws.
  • Fig. 4 shows a schematic perspective, partially sectioned view of a polarizing device according to the invention.
  • the regions of the polarization device, via which the contact devices are coupled to the bone screws can be surrounded by insulating jackets 36, 38.
  • These insulating jackets 36, 38 prevent stimulated bone formation around the isolated areas, thereby facilitating explantation of the polarizer.
  • Fig. 5 shows an application example of an implantation system according to the invention. It is shown how a polarization device according to the invention can be arranged in the region of a tumor 54 in the tibial plateau 56.
  • Another application example is the screw osteosynthesis of medial femoral neck fractures, in which several, for example, three screws are used, which can be functionally connected to one another in the form of the polarization device according to the invention.
  • Fig. 6 shows an example of the arrangement of electrical components in a polarizing device according to the invention.
  • an accumulator 58 may be arranged parallel to the coil 20, an accumulator 58 may be arranged.
  • a rectifier 60 which is represented here by a diode symbol, is also connected in parallel with the arrangement of accumulator 58 and coil 20.
  • the accumulator 28 is placed in close proximity to the coil 20 so that, when sufficient space is available, the coil 20 is placed in the cavity of an implant.
  • the contact pushbuttons 34 one of which is shown by way of example, then only have to carry a single electrical connection.
  • Fig. 7 shows a further example of the arrangement of electrical components in a polarizing device according to the invention.
  • the accumulator 58 is also arranged electrically parallel to the coil 20, but in the vicinity of the contact push button 34. This solution is preferred when the cavity of the implant, which accommodates the coil 20, for the accumulator 58 and the coil 20 is not sufficient.
  • the accumulator 58 is preferably housed in another implant. In this case, two electrical leads from the region of the implant carrying the coil 20 must be routed to the implant carrying the accumulator 58, which of course can be accomplished by a single cable.
  • the parallel connection of an accumulator 58 to the coil 20 makes it possible to charge the accumulator 58 when the coil 20 is in an external magnetic field.
  • the accumulator 58 serves as a voltage supplier for a function generator 62 as shown in FIG Fig. 7 is shown, this can by suitable contacts of its outputs with the electrically conductive areas of the implants (not shown here) provide an AC voltage even in the absence of an external magnetic field.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Radiology & Medical Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Neurology (AREA)
  • Cell Biology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Cardiology (AREA)
  • Prostheses (AREA)
  • Electrotherapy Devices (AREA)
  • Magnetic Treatment Devices (AREA)
EP10732290.1A 2009-06-30 2010-06-30 Polarisationsvorrichtung und implantationssystem Not-in-force EP2467190B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102009031134 2009-06-30
PCT/EP2010/003954 WO2011000556A2 (de) 2009-06-30 2010-06-30 Polarisationsvorrichtung und implantationsvorrichtung

Publications (2)

Publication Number Publication Date
EP2467190A2 EP2467190A2 (de) 2012-06-27
EP2467190B1 true EP2467190B1 (de) 2014-03-05

Family

ID=42665043

Family Applications (1)

Application Number Title Priority Date Filing Date
EP10732290.1A Not-in-force EP2467190B1 (de) 2009-06-30 2010-06-30 Polarisationsvorrichtung und implantationssystem

Country Status (5)

Country Link
US (1) US9474900B2 (zh)
EP (1) EP2467190B1 (zh)
CN (1) CN102481451B (zh)
AU (1) AU2010268372A1 (zh)
WO (1) WO2011000556A2 (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11331504B2 (en) 2018-04-10 2022-05-17 Neue Magnetodyn Gmbh Bipolar bone anchor with connection for electrostimulation

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US10307167B2 (en) 2012-12-14 2019-06-04 Corquest Medical, Inc. Assembly and method for left atrial appendage occlusion
US10813630B2 (en) 2011-08-09 2020-10-27 Corquest Medical, Inc. Closure system for atrial wall
US10314594B2 (en) 2012-12-14 2019-06-11 Corquest Medical, Inc. Assembly and method for left atrial appendage occlusion
US20140142689A1 (en) 2012-11-21 2014-05-22 Didier De Canniere Device and method of treating heart valve malfunction
US8679189B1 (en) * 2013-02-11 2014-03-25 Amendia Inc. Bone growth enhancing implant
US10838406B2 (en) 2013-02-11 2020-11-17 The Aerospace Corporation Systems and methods for the patterning of material substrates
US9566443B2 (en) 2013-11-26 2017-02-14 Corquest Medical, Inc. System for treating heart valve malfunction including mitral regurgitation
US10842626B2 (en) 2014-12-09 2020-11-24 Didier De Canniere Intracardiac device to correct mitral regurgitation
WO2017147599A1 (en) 2016-02-26 2017-08-31 Cimphoni Life Sciences LLC Light emitting bone implants
US20180085573A1 (en) 2016-09-27 2018-03-29 National Guard Health Affairs Skull implanted electrode assembly for brain stimulation
US10751527B2 (en) 2016-10-03 2020-08-25 II Erich W. Wolf Device and method for percutaneous placement and anchoring of stimulating electrodes in spine
US11305112B2 (en) 2018-05-16 2022-04-19 DePuy Synthes Products, Inc. Electrical stimulation implants

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Publication number Priority date Publication date Assignee Title
DE2311817C2 (de) 1973-03-09 1984-06-07 Werner Dipl.-Ing. 8000 München Kraus Reizstromgerät zur Förderung der Heilung von Knochenschäden
DE3240592A1 (de) 1982-11-03 1984-05-03 Werner Dipl.-Ing. 8000 München Kraus Implantierbare vorrichtung zur stimulation des knochenwachstums
DE3942735A1 (de) 1989-12-22 1991-06-27 Werner Kraus Aufnehmerspule fuer ein reizstromgeraet zur heilung von knochenschaeden
DE4230181A1 (de) * 1992-09-09 1994-03-10 Kraus Werner Implantat zur Elektrostimulation von Gewebe
US5292252A (en) * 1992-12-14 1994-03-08 Impla-Med, Inc. Stimulator healing cap
DE19928449C1 (de) 1999-06-23 2001-03-08 Geot Ges Fuer Elektro Oseto Th Knochenschraube mit Vorrichtung zur Elektrostimulation
DE102007063027A1 (de) * 2007-12-28 2009-07-09 Neue Magnetodyn Gmbh Kontaktvorrichtung für die Osteosynthese

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11331504B2 (en) 2018-04-10 2022-05-17 Neue Magnetodyn Gmbh Bipolar bone anchor with connection for electrostimulation

Also Published As

Publication number Publication date
CN102481451B (zh) 2014-10-15
WO2011000556A3 (de) 2011-03-03
US20120277812A1 (en) 2012-11-01
EP2467190A2 (de) 2012-06-27
AU2010268372A1 (en) 2012-02-23
CN102481451A (zh) 2012-05-30
US9474900B2 (en) 2016-10-25
WO2011000556A2 (de) 2011-01-06

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